info@benkana-interfaces.com
+49 431 88881400Human Factors and Usability Engineering
for international markets
We work with medical device and IVD manufacturers to design, test and document safer and Market‑Ready Medical Devices.
We navigate international Human Factors and usability requirements for fast and predictable market access of medical devices and IVD fitting the local context of use.
We strengthen your risk management and design control by applying tailored, aligned and coordinates usability engineering methods.
Help your worldwide customers sell and use your devices more confidently. We provide independent Human Factors and Usability results you can turn into strong sales arguments, protect your marketing claims and minimize complaints.
Turn Human Factors from “extra cost” into a lever for market access and product success. We help you choose the right level of usability work for your portfolio and target markets.
Reduce the risk of delays and findings related to Usability and Human Factors. We create lean, standards‑aligned documentation that fits worldwide regulatory expectations.
Make sure your device works in real clinical workflows, not only on paper. We test with real users in realistic settings and give your team concrete input for design decision, so you can make confident product decisions.
We help turning high‑level ideas into the right products by grounding roadmaps in real user needs and workflows. Together, we define a clear product strategy and then make sure the qualities your markets expect – safety, usability and differentiation – are actually realised in the final device.
We support usability and Human Factors teams as a flexible extension of their own expertise. You can rely on us for targeted seminars, on‑the‑job coaching in real projects, and flexible support to absorb workload peaks – so your team stays effective, up‑to‑date and able to focus on the most critical tasks.
How we help
Instead of “one‑size‑fits‑all” checklists, we design a Human Factors and Usability approach that fits your device, risk level and development stage. Our work combines strategy, user research, testing, ergonomics and documentation.
How to work with us
Working with Benkana Interfaces is straightforward and scalable to your needs.
1. Short call (20 minutes)
We discuss your device, target markets, risk profile and current status of your usability and Human Factors work.
2. Tailored HF/Usability proposal
You receive a focused proposal for Human Factors and usability support – from a compact review of your existing documentation to a complete plan including testing and reporting. Agile budgets are possible.
3. Execution and documentation
We carry out the agreed activities, from planning and recruiting to testing, analysis and creation of ready‑to‑review reports and files for your submission or audit.
Human Factors & Usability Strategy for international markets
- Clarify what Human Factors and Usability activities are expected for your device type and risk class in your markets.
- Define a lean, tailored Human Factors and Usability plan that aligns with your existing development and quality system.
- Integrate Usability work with Risk Management, Design Control and Accompanying Documentation.
Usability Testing with Real Users
- Plan and conduct formative and summative usability tests in realistic environments – such as operating rooms, ICUs, laboratories and home‑care settings.
- Recruit representative users: physicians, nurses, lab staff, patients and caregivers, reflecting relevant physiological and psychological characteristics.
- Observe real tasks, identify use errors and usability problems, and quantify user performance where needed.
Documentation for IEC 62366‑1, US FDA, China NMPA, UK MHRA
- Create or review your Usability Engineering File according to IEC 62366‑1, including use specification, hazard‑related use scenarios and evaluation records.
- Support Human Factors documentation for FDA submissions, including critical task analysis, Human Factors Validation Testing and final reports.
- Scale lean processes to comply with China NMPA according to your use-risk-level and an equivalent product analysis on the Chinese market especially with respect to the best usability evaluation strategy.
- Ensure traceability from user needs and use‑related risks to design decisions, risk controls and test results.
IEC 62366-1:2015
+ AMD1: 2020
FDA
HEF Guidance 2016/Draft 2022
NMPA
China Usability Guide
MHRA
UK Standards
ISO 14971:2019
Risk Management
ISO 13485:2016
QMS / Design Control
Ergonomics, Anthropometry and Biomechanics
- Translate worldwide anthropometric data into product dimensions, adjustability ranges and interaction layouts for your target user groups.
- Optimize physical interaction – handles, controls, wearable systems and carried loads – for comfort, safety and performance.
- Use biomechanical and physiological measurements (e.g. motion capture, pressure distribution, EMG, body climate) to support your design decisions with objective data.
Why Benkana Interfaces
Benkana Interfaces is a specialized partner for Human Factors, Usability, Ergonomics and Anthropometry in medical and human‑related products. We combine scientific depth with practical project experience and regulatory understanding.
- Focus on medical and human‑related products: We work on complex devices and workflows in hospitals, labs and home‑care.
- Scientific foundation: Our team brings expertise in anthropology, psychology, biomechanics and ergonomics into your product development.
- Realistic test environments: We can support studies in simulated ORs, ICUs, lab settings and neutral test rooms, and help you access real clinical environments where appropriate.
- Comprehensive user panels: Our tester pools go beyond age and profession and include detailed anthropometric, biomechanical and psychological characteristics – for more precise and representative testing.
- Standards‑aligned work: We work along the following standards and local guidance so that your usability work can be understood by Notified Bodies and international agencies.
- IEC 62366‑1-1:2025+AMD1:2020 Medical devices – Part 1: Application of usability engineering to medical devices
- FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices (2016)
- ISO 14971:2019 – Medical devices — Application of risk management to medical devices
- IEC 60601-1-6: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- NMPA guidance: Guideline of usability engineering review for medical devices (2024)
- MHRA guidance Guidance on applying human factors and usability engineering to medical devices including drug‑device combination products in Great Britain” (2021, v2.0)
